By Adria Calatayud
Galderma Group failed to secure approval from the U.S. Food and Drug Administration for its latest antiwrinkle treatment, hitting a setback in its bid to launch a new rival to AbbVie's Botox.
The Swiss skincare group said Wednesday that it was putting in place corrective and preventive actions to address issues raised by the FDA. The product is already approved in some countries and marketed as Relfydess, and Galderma said advancing it in the U.S. remains a top priority.
This marks the second time in the past three years that the FDA has turned down an application from Galderma for the injection, also known as relabotulinumtoxinA.
Shares in Galderma fell as much as 6.9% on Wednesday, in one of the worst sessions for the company since it went public in March 2024.
While Botox remains firmly in the lead of the aesthetic-drug market it helped usher in, a growing number of companies are seeking to launch competing products. Galderma already sells Botox rival Dysport for cosmetic use and has other injectable-aesthetic products in its portfolio.
In Relfydess, Galderma saw a drug with potential to become a blockbuster and narrow the gap with Botox. Executives have said the injection gained traction quickly in the first markets where it became available, Germany and Spain, securing the No. 3 spot by market share after Botox and Dysport.
Galderma said the FDA's complete response letter declining its application mentioned observations during an inspection of its manufacturing site, and comments related to its analytical method. All other aspects of the submission, including safety and efficacy, didn't present deficiencies to be addressed, it added.
The company said it plans to rapidly respond to the FDA letter, which doesn't affect approvals, launches, or regulatory reviews in other markets.
The FDA already rejected Galderma's initial application for Relfydess in October 2023, citing deficiencies related to chemistry, manufacturing, and controls processes, the company said at the time.
Galderma's efforts to launch Relfydess in the U.S. are likely to be delayed by between nine months and a year, analysts at Jefferies wrote in a note to clients. The FDA's decisions underscore the complexity of manufacturing so-called neurotoxin drugs, but it doesn't reduce the chances of approval, they added.
South Korean medical-aesthetics specialist Hugel was also turned down twice by the FDA before it got the green light for its Letybo treatment in 2024. The manufacturer of Daxxify--another Botox rival that is now made by Crown Laboratories--also hit hurdles before it obtained U.S. approval in 2022, and AbbVie in April said the FDA requested additional information on its next-generation neurotoxin.
Relfydess, derived from bacteria and developed specifically for use in aesthetics, was one of the sources of disagreements between Galderma and long-standing partner Ipsen that ended up in arbitration cases between the two companies.
Ipsen is developing its own Botox rival, corabotase, and has said it is assessing commercialization options.
Write to Adria Calatayud at adria.calatayud@wsj.com